At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
nonacog beta pegoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B
In Brief
A Phase 3 clinical trial evaluating nonacog beta pegol for Congenital Bleeding Disorder and Haemophilia B. Completed, enrolled 25 participants across 51 sites in 12 countries.
Detailed Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Haemophilia B
CountriesBrazil, Canada, Croatia, France, Germany, Italy, Japan, Malaysia, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartMay 2012
Primary CompletionNov 2023
TodayJul 2026
First PostedNov 8, 2011
Enrollment StartMay 16, 2012
Primary CompletionNov 17, 2023
TodayJul 2, 2026
Enrollment to primary: 11.5 yearsPosted 14.7 years ago
Interventions
nonacog beta pegoldrug
A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.